DRG Salivary Testosterone ELISA- IVD for the detection of Testerone… — Class II medical device recall Z-2159-2019
Terminated recall by DRG Instruments GmbH, reported 2019-08-14, distributed nationwide. Salivary assay may observe a higher percentage of samples with 0 pg/ml testosterone or results which are too l
| Recall number | Z-2159-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DRG Instruments GmbH, Marburg, N/A, Germany |
| Recall initiated | 2019-05-21 |
| Classified | 2019-08-05 |
| Reported by FDA | 2019-08-14 |
| Terminated | 2020-05-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CA, CN, PL |
| Quantity | 38 kits |
| Reason classes | potency |
| Lot numbers | 66K019, 66K118 |
| Model numbers | SLV-3013 |
Product
DRG Salivary Testosterone ELISA- IVD for the detection of Testerone in human saliva Catalog # SLV-3013 Product Usage: The Salivary Testosterone ELISA (SlV-3013) is an enzymatic in vitro Assay for the detection of Testosterone in human Saliva. Testosterone levels are measured in fertility studies in men and women. Fertility problems are not diagnosed on the outcome of Testosterone alone but accompanied by other diagnostic means
Reason for recall
Salivary assay may observe a higher percentage of samples with 0 pg/ml testosterone or results which are too low. Saliva samples in the low measuring range of the kit(< 50 pg/ml) were assayed significantly lower
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2159-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.